Diabetes Mellitus, Type 2, Insomnia
Conditions
Keywords
cognitive behavioral treatment
Brief summary
This study will test the effect of the an insomnia intervention with cognitive behavioral treatment delivered via web compared with an information control group on glucose control and self management behavioral in a sample of persons with type 2 diabetes (T2DM).
Detailed description
Recent evidence supports that insomnia is a prevalent problem among persons with type 2 diabetes that may be associated with increased daytime sleepiness and fatigue, increased diabetes-related distress, decreased self-management behavior, and worse glycemic control. The main hypothesis of the current application is that a web-based cognitive behavioral treatment of insomnia (Sleep Health Using the Internet: SHUTi) in persons with T2DM will not only improve their nighttime sleep, but also improve their ability to integrate diabetes education into their daily behavior and positively affect their glucose control compared to a web-based Information Control (IC) group. The aims of this study are to 1) obtain preliminary data to facilitate further hypothesis development and enhance the feasibility of conducting a randomized clinical trial to examine if treatment of insomnia results in participant's being better able to integrate diabetes education into their self-management behavior and result in improved glucose control, 2) explore the associations among changes in insomnia severity, fatigue, daytime sleepiness, sleep quality, A1C (a measure of glucose control over the last three months) and diabetes self-management (DSM) behaviors, 3) explore average pre-intervention to post-intervention changes in insomnia severity, daytime symptoms (fatigue, sleepiness, mood) and DSM behaviors (diet and physical activity) in subjects treated with SHUTi + DSM compared to IC + DSM subjects at 3 months, and 4) explore sleep fragmentation as a potential physiological mechanism linking impaired glucose control (A1C) and sleep in subjects with insomnia and T2DM at baseline and 3 months.
Interventions
BEHAVIORALInsomnia Intervention
The SHUTi intervention is based on a cognitive behavioral treatment for insomnia (CBT-I) and organized into six structured, weekly online sessions. Each week the participants will complete a 30-minute interactive learning module and to complete daily online sleep diaries will be used.
OTHERInformation Control
Information on websites that are general health promoting
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two group design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (1) T2DM with suboptimal glucose control * (2) age 18 years or older; * (3) willing to be randomized to SHUTi or IC group; * (4) able to speak, read, and write in English, and * (5) insomnia symptoms with at least one daytime consequence \[e.g. impaired mood, poor sleep quality, excessive daytime sleepiness, fatigue\].
Exclusion criteria
* Type 1 or gestational diabetes * Change in oral medications or \> 10% change in insulin in last 3 months * Acute medical or psychiatric illness or hospitalization ≤ 3 months (such as angina, stroke, major surgery, major depression or serious psychiatric conditions) * AHI (apnea-hypopnea index; apnea \[cessation of breathing\] or hypopnea \[reduction in breathing\]) ≥ 10 episodes an hour on overnight sleep study * Non-ambulatory * Self-reported epilepsy, psychotic or bipolar disorder * History of near-miss or auto accident during last 12 months * Employed in safety sensitive job (e.g. truck driver or airline pilot) * Working nights or rotating shifts * Regular use of alerting (e.g., modafinil) medications * Consumption of alcohol: Men: \> 4 drinks a day or \> 14 drinks per week * Women: \> 3 drinks a day or \> 7 drinks per week * If using sleep medications, the drug and/or dose changed in the past month * Depression * Medications for psychotic or bipolar disorders * No internet access * Pregnant or intend to become pregnant in the next four months (postmenopausal or confirmed not pregnant by a urine pregnancy test)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Glucose Control for Last 3 Months Assessed by A!C level | After 12 weeks of either the insomnia intervention or the information control intervention | A1C level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | After 12 weeks of either the insomnia intervention or the information control intervention | Scores on the Pittsburgh Sleep Quality Index questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity | After 12 weeks of either the insomnia intervention or the information control intervention | Scores on the Insomnia Severity Index questionnaire |
Countries
United States
Outcome results
None listed